What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) often target the renin-angiotensin-aldosterone system (RAAS) to reduce kidney damage and slow disease progression. Finerenone, an aldosterone blocker, works by inhibiting the effects of aldosterone, a hormone that can cause inflammation and fibrosis in the kidneys and heart. By blocking aldosterone, finerenone helps to reduce these harmful effects, thereby protecting kidney function and potentially slowing the progression of CKD. This is crucial for CKD patients as it can help maintain kidney function for a longer period and improve overall health outcomes.

What side effects are associated with this type of intervention?

Common side effects of aldosterone antagonists, such as those being studied in the trial for finerenone, include hyperkalemia (elevated potassium levels), gynecomastia, menstrual irregularities, and gastrointestinal issues like nausea and vomiting. There is also a theoretical concern for an increased risk of breast cancer with spironolactone, although this has not been definitively proven. Monitoring for these side effects is essential during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Kidney Disease (CKD), particularly those targeting the renin-angiotensin-aldosterone system (RAAS). Spironolactone and eplerenone, both aldosterone blockers, have been used to manage CKD by reducing proteinuria and slowing disease progression. These drugs work by blocking the effects of aldosterone, a hormone that can cause kidney injury and inflammation. Additionally, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are commonly prescribed to manage CKD by controlling blood pressure and reducing proteinuria. These treatments have shown efficacy in slowing the progression of CKD and improving cardiovascular outcomes.

What other types of research exist?

Promising alternatives to Finerenone for CKD patients include: 1) Spironolactone and Eplerenone, which are other aldosterone antagonists with proven efficacy in reducing mortality and slowing CKD progression. 2) Angiotensin receptor blockers (ARBs) like Losartan and Valsartan, which have shown benefits in renal protection. 3) Angiotensin receptor neprilysin inhibitors (ARNIs) such as Sacubitril-Valsartan, which may offer additional cardiovascular and renal benefits. 4) Sodium-glucose co-transporter-2 (SGLT2) inhibitors like Dapagliflozin and Empagliflozin, which have demonstrated significant renal and cardiovascular protective effects in CKD patients.

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Mineralocorticoid Receptor Antagonist

Finerenone for Chronic Kidney Disease (FIND-CKD Trial)

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥ 25 but < 90 mL/min/1.73m^2 at screening

A clinical diagnosis of chronic kidney disease

Must not have

Autosomal dominant or autosomal recessive polycystic kidney disease

Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to month 32

Awards & highlights

Pivotal Trial

Summary

This trial is testing finerenone, a daily pill, to help people with non-diabetic chronic kidney disease. Finerenone works by blocking a hormone called aldosterone that can cause damage and swelling in the heart and kidneys. The goal is to see if finerenone can slow down the worsening of kidney disease. Finerenone has shown promise in reducing kidney disease progression in patients with chronic kidney disease and type 2 diabetes.

Who is the study for?

Adults with non-diabetic chronic kidney disease (CKD) can join this trial. They must have a certain level of protein in their urine and a specific range of kidney function. Participants should be on stable doses of ACE inhibitors or ARBs for at least 4 weeks before the trial starts, without severe heart failure or diabetes, and not require immunosuppressive therapy for other kidney diseases.

What is being tested?

The trial is testing if finerenone, a tablet taken once daily that blocks the hormone aldosterone, can slow down CKD progression compared to a placebo. The study will last up to about 50 months and involves regular health checks plus blood and urine tests while continuing current CKD medications.

What are the potential side effects?

Possible side effects include changes in blood potassium levels which could affect heart rhythm, potential impacts on kidney function, and general risks like allergic reactions or gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney tests show specific levels of protein in my urine and a certain rate of filtration.

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I have been diagnosed with chronic kidney disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a genetic form of polycystic kidney disease.

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I have a kidney condition treated with immune-suppressing drugs in the last 6 months.

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I have been diagnosed with Type 1 or Type 2 Diabetes, or my HbA1c level is 6.5% or higher.

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I have heart failure with a need for specific heart medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 32

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 32

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 32 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.

Side effects data

From 2020 Phase 3 trial • 5734 Patients • NCT02540993

15%

Hyperkalaemia

Nasopharyngitis

Anaemia

Hypertension

Oedema peripheral

Upper respiratory tract infection

Diarrhoea

Urinary tract infection

Glomerular filtration rate decreased

Back pain

Constipation

Hypoglycaemia

Arthralgia

Dizziness

Bronchitis

Pneumonia

Acute kidney injury

Diabetic nephropathy

Hyperglycaemia

Cellulitis

Sepsis

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Finerenone

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Finerenone (BAY94-8862)Experimental Treatment1 Intervention

Participants will receive finerenone.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone (BAY94-8862)

2013

Completed Phase 3

~21330

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) often target the renin-angiotensin-aldosterone system (RAAS) to reduce kidney damage and slow disease progression. Finerenone, an aldosterone blocker, works by inhibiting the effects of aldosterone, a hormone that can cause inflammation and fibrosis in the kidneys and heart. By blocking aldosterone, finerenone helps to reduce these harmful effects, thereby protecting kidney function and potentially slowing the progression of CKD. This is crucial for CKD patients as it can help maintain kidney function for a longer period and improve overall health outcomes.

Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Deleting Death and Dialysis: Conservative Care of Cardio-Vascular Risk and Kidney Function Loss in Chronic Kidney Disease (CKD).Does cardiovascular protection translate into renal protection?